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Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01147835
First received: June 11, 2010
Last updated: June 23, 2010
Last verified: June 2010

June 11, 2010
June 23, 2010
October 2009
December 2010   (final data collection date for primary outcome measure)
Levels of oral Streptococcus mutans [ Time Frame: Measured at baseline and 6 months. ] [ Designated as safety issue: No ]
The count of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs).
Levels of oral Streptococcus mutans [ Time Frame: Changes will be measured over a 6-Month Period. ] [ Designated as safety issue: No ]
The count of S. mutans will be obtained by culture and be expressed in colony forming units.
Complete list of historical versions of study NCT01147835 on ClinicalTrials.gov Archive Site
DMFT/dmft score changes [ Time Frame: Measured at baseling and 6 months. ] [ Designated as safety issue: No ]
Decayed, missing and filled teeth (DMFT/dmft) score is an index for measuring dental caries.
DMFT/dmft score changes [ Time Frame: Changes will be measured over a 6-Month Period. ] [ Designated as safety issue: No ]
DMFT/dmft is an index for measuring dental caries.
Not Provided
Not Provided
 
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
Effects of Herbal Lollipops on Streptococcus Mutans Levels and the Dental Caries Experience of Children With Asthma Taking beta2-adrenergic Agonist Drugs

Young children with asthma who use drugs for their asthma are at higher risk for tooth decay. These drugs can cause (1) dry mouth from less saliva secretion and (2) acid mouth that causes teeth to become soft and bacteria to multiply. Herbal lollipops may reduce the risks of tooth decay in young children. The purpose of this research is to determine how well herbal lollipops can improve the negative effects of asthma drugs over a 6-month period. Herbal lollipops contain Chinese licorice root.

This study is entitled, "Effects of herbal lollipops on Streptococcus Mutans levels and the dental caries experience of children with asthma taking beta2-adrenergic drugs." In this study, forty-five (45) children between the ages of four (4) and sixteen (16) with bronchial asthma taking a beta2-adrenergic agonist drug at least once a week will participate in a six (6) month regimen of herbal lollipops as adjunctive oral hygiene therapy. The objective of this study is to determine how effective the six-month regimen of herbal lollipops is at controlling the Streptococcus Mutans levels and the caries process in the study group. Whether or not a case can be made for including herbal lollipops in standard oral hygiene protocol for children with asthma will also be a goal of this study. Relevant data will be collected using the following method. The subjects of this study will be provided with and instructed to dissolve two (2) herbal lollipops by mouth per day for the first ten (10) days of the study and again for ten (10) days three (3) months into the study. Each subject will receive a total of forty (40) lollipops for the study. The study group will be matched with a control group of forty-five (45) children who also have asthma and who take beta2-adrenergic agonist drugs as needed for symptoms. The children in the control group will be given placebo lollipops and will be instructed to use them in the manner described above. All ninety (90) subjects will be drawn from the collective patient pools of the UNMC College of Dentistry in Lincoln, NE, and the UNMC Pediatric Dentistry and UNMC Pediatrics Clinics in Omaha, NE. Oral hygiene instructions will be given to all participating subjects at the onset of the study. Entrance Streptococcus mutans levels and decayed, missing and filled teeth scores (DMFT/dmft) will be determined on the subjects and changes over the six (6) month study will be compared and evaluated. If some stabilization or improvement in the Streptococcus mutans levels and/or dental caries experience in the study group is shown, such promising results will allow for implementation of longer-term studies. The significance of this study is that adjunctive oral hygiene therapy that employs herbal lollipops may prove to help children who suffer from bronchial asthma lower their dental caries risks and have healthier oral environments unburdened by the effects of their medication and condition.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Asthma
  • Dental Caries
Dietary Supplement: Chinese Licorice Root
Chinese Licorice Root lollipops are given to the subjects in the study group to ingest twice daily for 10 days. Then the subjects must wait 3 months, and then again ingest the lollipops twice daily for 10 days.
Other Name: Herbal lollipops, Glycyrrhiza uralensis
  • Placebo Comparator: Placebo Lollipop
    The placebo group will ingest the same herbal lollipop formula without the active ingredient.
    Intervention: Dietary Supplement: Chinese Licorice Root
  • Experimental: Chinese Licorice Root
    The experimental group will ingest the herbal lollipop formula with the active ingredient.
    Intervention: Dietary Supplement: Chinese Licorice Root

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
May 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have a medical diagnosis of asthma and must use a beta2-adrenergic agonist inhaler or nebulizer for their symptoms as needed.
  • Must not have any other serious medical conditions that require taking another illness-related medication that may cloud the study results. (i.e. medications that have been shown to have anti-sialogogue effects.
  • Must not have a history of severe early childhood caries (SECC) or "baby bottle tooth decay."
  • Must fall within the age range of four (4) to sixteen (16) years old.
  • Must be available to return for data collection during six (6) months of participation in the experiment.

Exclusion Criteria:

  • Children who do not fall within all the aforementioned inclusion criteria will not be considered for participation in this study.
Both
4 Years to 16 Years
Yes
Contact: Angela Cook, BA 720-284-8999 angela.k.cook@gmail.com
Contact: Scott Hamilton, DDS (402) 472-1306 shamilton@unmc.edu
United States
 
NCT01147835
337-09
Yes
Angela Cook, University of Nebraska Medical Center College of Dentistry
University of Nebraska
Not Provided
Not Provided
University of Nebraska
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP